Medtronic
Infuse Bone Graft has been used in numerous fusion surgeries
and may cause an increased risk of cancer, nerve damage, or
death. Persons that have had fusion surgery where
Infuse has been used and then been diagnosed with cancer or
nerve damage should report the health issues to their
physician and the FDA. Additionally, families that
have lost a loved one to cancer, nerve damage, organ
failure, or respiratory failure after a fusion surgery
should also contact the FDA regarding the death.

Medtronic Infuse Bone
Graft is a product that has been commonly used in back
fusion surgeries since 2002. The product contains
recombinant human Bone Morphogenetic Protein (rhBMP) which
is a genetically engineered protein that initiates bone
growth. The Infuse Bone Graft was approved by the FDA for
use in some specific back surgeries, but has not been
approved for neck surgery. The FDA has received more
than 200 adverse reports from the Infuse product including
patients that have suffered swelling of the neck tissue,
which constricted their airways, requiring an emergency
tracheotomy, feeding tube, and more surgery.

Persons who have had a back fusion
surgery which included the use of Infuse Bone Graft and families of
these people should be aware of and report any of the following post
surgery adverse health events:

Cancer

Difficulties swallowing,
speaking, or breathing

Angioedema (swelling of the neck
and throat, which can cause fatal suffocation)

Compression of airway

Impingement of nerves and nerve
damage

Unwanted bone growth

Male sterility

Paralysis

Emergency surgery

Disability

Death

Metronic Infuse Bone Graft
Lawsuits

The Manufacturer of the Infuse Bone
Graft product is Medtronic. Medtronic is facing over 3,000
lawsuits alleging adverse health events from the Infuse Bone Graft
product. These Infuse Bone Graft lawsuits have not been consolidated
into a MDL or class action lawsuit. Instead, the cases are individual
lawsuits filed by plaintiffs with severe injuries. In May 2014,
Medtronic agreed to settle 950 lawsuits for $22 million. They have set
aside $120-140 million to settle thousands of additional claims. The
Infuse Bone Gaft lawsuits include allegations that Medtronic sales
personnel encouraged doctors to use the Infuse Bone Graft for off-label
procedures that were not approved by the FDA. Further, these lawsuits
allege that Medtronic paid physicians to fraudulently create false
studies regarding the Infuse Bone Graft product in an effort to mislead
doctors and the public about the use of the product and that Medtronic
failed to adequately warn of the dangerous side effects associated with
the Infuse Bone Graft product.

Spinal Fusion Surgery

Spinal Fusion Surgery
uses a bone graft to stop motion and impingement in the
spine, thus reducing the patient's pain. A Lumbar
Spinal Fusion uses a bone graft in the lumbar or lower part
of a person's back to stop the motion at a painful vertebral
segment for the purpose of decreasing pain generated from
the damaged part of the lumbar or lower back. A
Cervical Spinal Fusion uses a bone graft in the cervical or
neck/upper back to stop the motion at a painful vertebral
segment for the purpose of decreasing pain generated from
the damaged part of the cervical back, upper back, or neck.

Unfortunately, spinal
fusions can fail for several different reasons. A
common reason for a failed fusion is that the patient's
spine does not properly fuse. An example of this type
of fusion failure occurs when there is not enough support to
hold the spine, while the spine is fusing. These
failed fusions can be caused by hardware failures. In
these situations, spinal hardware such as pedicle screws can
be misplaced or can be defective causing the internal splint
to fail. The internal split is intended to hold the
spine while the fusion takes place after spine surgery.
Its failure can cause spinal instability and prevent the
fusion from being able to fully fuse. Other potential
reasons for a failed fusion include that the fusion does not
stop the impingement or the fusion causes problems in other
areas of the spine.

In general, surgeons
estimate that it takes at least three months to get a solid
fusion after surgery, and it can take up to a year in some
patients to get a solid fusion after the spine surgery.
Therefore, in some patients with unstable spines, after
surgery it can sometimes be a race between the spine fusing
(patient’s bone providing support for the spine) and the
metal failing (causing fusion failure). It is
therefore important to have follow up care after surgery and
for the patient to be advised as to the potential dangers of
applying too much stress on the back during the healing
process. It is also important for the hardware that is
implanted in a patient to be able to last long enough for a
solid fuse to occur.

Also, it is important to keep in mind
that even if a solid fusion is not obtained through the
spine surgery, the hardware if it does keep intact and
provides good stability to the spine, the patient may still
achieve effective back pain relief with the spine surgery.
In many cases, achieving spinal stability alone is more
important than obtaining a solid fusion from the spine
surgery.

In some patients, the
decompression surgery will sometimes de-stabilize the spine
and create the need for a fusion to add stability. In these
cases spinal instrumentation (such as a small plate) can
also be used to help add stability to the spinal construct.
Depending on the patient's cervical impingement an
Ananterior Cervical Decompression Surgery (Discectomy) or a
Posterior Cervical Decompression (Microdiscectomy) and
Fusion Surgery (Discectomy) or a combination of operating
from the front and back of the patient may be used.

The decompression
and fusion surgeries are often used together because
decompression surgery involves removing a small portion of
the bone which will often result in spine instability.
Thus, decompression surgery or a laminectomywill sometimes de-stabilize the spine and create the
need for a fusion to add stability. In these cases a
internal splint or spinal instrumentation (such as a small
plate and pedicle screws) can also be used to help add
stability to the spinal construct. This decompression and
fusion surgery includes Cervical Decompression and Fusion
Surgery as well as Lumbar Decompression and Fusion Surgery.

Unfortunately, some
careless surgeons will fail to stabilize the spine during a
decompression surgery resulting in spine instability that
can result in severe pain, paralysis, or disability.
Other surgeons can fail to remove the bone or anatomical
lesion (injury) that is causing the impingement and pain.
Both of these failures can result in the need for additional
surgeries.

Fusion and Decompression
Surgery by its nature involves incisions into and
manipulation of the spine, surrounding nerves, and tissue,
any mistake by a surgeon during the surgery can have
potentially serious injuries and damages for the patient.
These injuries and damages can include permanent nerve
injuries, blood clots, incontinence, and even death if the
surgery does not go as planned. Additionally, a medical
professionals’ failure to monitor patients for potentially
crippling and/or fatal side effects can be medical
malpractice should these injuries occur.

In addition to the above
back surgeries, there are numerous implants and spinal
devices as well as injections that can help people recover
from back and spinal cord injuries. These procedures
and devices can reduce pain caused by back injuries as well
as help reduce impairment. However, it is extremely
important when considering back surgery or other spinal
procedures to make sure that you have a competent doctor and
medical staff that you trust. A
failed back surgery or defective medical device can
cause more impairment, pain, and health problems than none
at all. It is important to understand the risks of any
back surgery or medical treatment.

Further, it is important
to understand that some medical doctors feel that too many
surgeons are using back stimulators for treating back pain
when the indication is for neuropathic pain instead.
It is extremely important to have a medical doctor and
surgical team that understands the cause of your back pain
and properly treats the underlying cause rather than uses an
implant or improper surgical procedure to mask pain.
Further, it is also important for the surgical team to
understand the proper methods for implanting any back
stimulator. Improper implantation of a back stimulator
can cause serious problems.